The Principles of Medical Device Decontamination

These higher conditions can also affect the stability of the biocide, causing its concentration to reduce much more quickly than under manufacturer-stated conditions. Because of these potential effects, disinfectants for medical devices should be used at the recommended parameters for concentration (dose), temperature range and exposure time.

Water quality

As mentioned above, commercially available disinfectants are usually aqueous solutions of the biocide. Biocides are often available in a concentrated form and will require dilution to the manufacturer-recommended concentration before use. The quality of the water used can influence the free availability of the biocide, so water used should be of a known quality and within the limits recommended by the disinfectant manufacturer. After the medical device has been disinfected, the residual disinfectant must be removed by rinsing. This rinse water should again be of a known quality and is typically filtered or treated to remove microbiological contamination in the rinse water, to prevent recontamination of the disinfected device. Filters with a nominal penetrating particle size of 0.2 µm or smaller may be suitable.

Disinfectant selection

Reusable medical devices should only be treated with disinfectants that are identified as compatible in the medical device IFU’s. Where these IFUs are not compatible with the processing equipment, the advice of decontamination professionals should be sought in order to ensure that disinfectants are chosen based on their efficacy and material compatibility. If the materials of the medical device are known, disinfectants that have a known compatibility with those materials may be used, however the temperature, disinfectant concentration and exposure time can all affect the material compatibility and biocompatibility.

A suitable disinfectant should:

• Be designed specifically for medical device disinfection • Have demonstrated efficacy against a broad spectrum of microorganisms • Not fix proteins • Have compatibility with the materials of construction of the reusable medical device

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